Clearance Summary
SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System received FDA 510(k) clearance under submission number K241813, sponsored by Si-Technology, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-08-13.
- Submission: K241813
- Applicant / Sponsor: Si-Technology, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2024-08-13
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.